Perampanel (2) – Fycompa®

Epilepsy, focal seizures, ≥ 12 years

Characteristics

Start date 15.05.2014 – Marketing authorisation: 23.07.2012
Resolution 06.11.2014
INN Perampanel
Brand name Fycompa®
Pharm. company Eisai GmbH
G-BA Procedure ID D-106
ATC code N03AX22 Other antiepileptics (N03AX)
ICD-10 codes (AIS) G40.08, G40.09, G40.1Attacks without alteration of consciousness, G40.2Attacks with alteration of consciousness, often with automatisms, G40.8Epilepsies and epileptic syndromes undetermined as to whether they are focal or generalized
Alpha-ID codes (AIS) I3557Focal epilepsy, I85633Epilepsy, undetermined whether focal or generalized, I90702Focal onset of epileptic seizure, I91470Epilepsy with complex focal seizure, I91514Idiopathic localization-related epilepsy
DDD 8 mg O
Therapeutic area Nervous system diseases Epilepsy
Reason for procedure Reassessment: §14 (manufacturer request)
Original resolution: Perampanel (1) (07.03.2013)
Specialty Patent/data protection expired

Therapeutic indication of the resolution

Fycompa (perampanel) is indicated for the adjunctive treatment of partial-onset seizures (POS) with or without secondarily generalised seizures in patients from 12 years of age and older.
Subpopulation Indication Comparator
Patients 12 years and older with focal seizures with or without secondary generalisation (add-on therapy) Patient individual antiepileptic add-on therapy with one of the following agents: Eslicarbazepine (adults) or Gabapentin or Lacosamide (patients over 16 years of age) or Lamotrigine or Levetiracetam or Oxcarbazepine or Pregabalin (adults) or Topiramate or Valproic acid or Zonisamide.

Studies and Results

No. of studies
(best subpopulation) 		3 (E2007-G000-304, E2007-G000-305, E2007-G000-306)
Study design
(best subpopulation) 		H2H vs. non-ACT + no ITC
Meta analysis
(best subpopulation) 		no

  • Clinical trials
    • The pharmaceutical manufacturer’s pool of studies designed to demonstrate the additional benefit of perampanel comprises three randomised controlled trials (RCTs; E2007-G000-304, E2007-G000-305 and E2007-G000-306). These studies are randomised, double-blind, placebo-controlled trials with a parallel-group design and a treatment phase of 19 weeks.

Adjunctive therapy for focal seizures with or without secondary generalisation in patients with epilepsy aged 12 years and over

  • For the adjunctive treatment of focal seizures with or without secondary generalisation in epilepsy patients aged 12 years and over, the additional benefit of perampanel compared with the appropriate comparator therapy is not proven.
  • The studies submitted by the pharmaceutical manufacturer are not suitable for assessing the additional benefit of perampanel compared with the G-BA’s appropriate comparator therapy. This is because the G-BA’s appropriate comparator therapy was not implemented in the studies.
  • In all three studies (E2007-G000-304, E2007-G000-305 and E2007-G000-306), the appropriate comparator therapy specified by the G-BA was not implemented; they are therefore not suitable for assessing the additional benefit compared with the G-BA’s appropriate comparator therapy.

Courtesy translation only, please refer to the German original.

Associated procedures



<< List of all resolutions